A trial looking at radiotherapy with or without chemotherapy for people with bladder cancer (BC2001)

Cancer type:

Bladder cancer
Transitional cell cancer

Status:

Results

Phase:

Phase 3

This trial compared radiotherapy and chemotherapy with radiotherapy alone for bladder cancer. And looked at different ways of giving radiotherapy. 

It was for cancer that had grown into the muscle layer of the bladder (invasive bladder cancer), but had not spread to another part of the body. It was supported by Cancer Research UK.

The trial was open for people to join between 2001 and 2008 and the team first published results in 2009. They published further results in 2021.

More about this trial

Doctors often treat invasive bladder cancer with surgery to remove the bladder (a cystectomy). But some people are not well enough to have, or don't want to have, this operation. They can often have radiotherapy instead. But sometimes the cancer comes back in the bladder after radiotherapy and they need more treatment.

Doctors wanted to find out if giving chemotherapy at the same time as radiotherapy would improve the treatment for bladder cancer. This is sometimes called chemoradiotherapy or chemoradiation. In this trial the doctors used the chemotherapy drugs fluorouracil (5-FU) and mitomycin C.

When doctors give radiotherapy for invasive bladder cancer, they usually use the same dose for the whole of the bladder. But this can cause side effects. So they wanted to find out if targeting the highest dose of the radiotherapy to the cancer, and reducing the dose to the rest of the bladder, could reduce the side effects. The researchers call this modified radiotherapy.

The main aims of the trial were to find out:

  • which treatment was best at reducing the risk of bladder cancer coming back
  • more about the side effects
  • if modified radiotherapy reduces side effects without increasing the risk of cancer coming back in the bladder

Summary of results

The trial team found that giving chemotherapy and radiotherapy at the same time did help stop bladder cancer coming back.

Trial design
A total of 458 people who had invasive bladder cancer took part in this trial. It looked at adding chemotherapy to radiotherapy, as well as 2 different ways of giving radiotherapy. People could choose to enter one or both parts of the trial.

For each part of the trial, people were put into treatment groups at random.

Results for chemoradiation
360 people joined the part of the trial which looked at chemoradiation:

  • 182 people had chemotherapy and radiotherapy
  • 178 people had radiotherapy alone

The trial team looked at how many people’s cancer had not started to grow again, 2 years after treatment. They found it was:

  • nearly 7 out of 10 people (67%) who had chemoradiation
  • more than 5 out of 10 people (54%) who had radiotherapy alone

The research team also looked at how many people were living 5 years after treatment. They found it was:

  • just under 5 out of 10 people (48%) who had chemoradiation
  • more than 3 out of 10 people (35%) who had radiotherapy alone

Side effects of chemoradiation 
A few more people who had chemoradiation had side effects during treatment that were mild or didn’t last long.

Most people had few or no long term side from the radiotherapy. The people who had chemotherapy and radiotherapy didn't have any additional long term side effects.

Results for modified radiotherapy
219 people joined the part of the trial which looked at different ways of giving radiotherapy:

  • 108 people had standard radiotherapy
  • 111 people had modified radiotherapy

The trial team found that changing the way of giving radiotherapy did not affect the risk of the cancer coming back or the side effects.

Conclusion
The team concluded that having chemotherapy and radiotherapy at the same time does help stop bladder cancer that had spread into the muscle cancer coming back. And doesn’t cause any more long term side effects. 

They suggest that chemoradiation is a good option for people who can’t have, or don’t want to have, an operation to remove their bladder.

Different doses of radiotherapy
In 2020 researchers combined the results for people who took part in two trials – this trial (BC2001) and another trial for bladder cancer called BCON

Radiotherapy is measured in Gray (Gy). You often have several doses called fractions Open a glossary item. Some people in each of these trials had 64Gy in 32 fractions. And others had 55Gy in 20 fractions. These were both common treatments for bladder cancer when the trials were done.

The research team combined the results from the 2 trials, to see how well people did.

They looked at the results for 326 people who took part in BCON, and 456 people who took part in BC2001. So a total of 782 people:

  • 376 who had 64Gy in 32 fractions
  • 406 who had 55Gy in 20 fractions

The results showed that, 5 years after treatment, the cancer had come back in fewer people who had 55Gy in 20 fractions. How long people lived for and the side effects they had were very similar in the two groups. 

Conclusion 
The research team concluded that 55Gy in 20 fractions is as good as 64Gy in 32 fractions, for bladder cancer that has grown into the bladder muscle wall. They suggest that 55Gy in 20 fractions should be the standard treatment for this group of patients.

Where this information comes from
We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Nick James
Professor Robert Huddart

Supported by

Birmingham University
Cancer Research UK
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/01/004.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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